RAIB-TACE for the Patients with Hepatocellular Carcinoma beyond Up-to 7 Criteria

Phase 2

• Conditions: Hepatocellular Carcinoma; Hepatocellular carcnioma, TACE; D006528

• Registration Number: JPRN-jRCTs031200334
• Lead Sponsor: Hoshiai Sodai

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-29
• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

1. Patients with hepatocellular carcinoma diagnosed by enhanced CT or MRI
2. Up to seven criteria out
3. need to treat two or more subsegmenta by TACE
4. Age: 20 years or older.
5. ECOG Performance Status: 0-1
6) Consent has been obtained from the patient.
7) The patient is expected to survive for at least 3 months after treatment.

Exclusion Criteria

1) Child-Pugh score is greater than or equal to 7.
2) Renal function with an eGFR of less than 40.
3) Tumor throat in portal vein branch or main stem or hepatic vein.
4) The largest tumor is greater than or equal to 15 cm in diameter.
5) Sarcomatous changes (over the course of 2-3 months, the tumor size increases 1.5-2 times or more in size and there is no increase in arterial blood flow. Alternatively, there is a ring of staining with irregular margins and no capsule structure and internal necrosis.
6) Lymph node involvement or distant metastasis.
7) Previous surgical biliary reconstruction or endoscopic bile duct treatment.
8) Dilation of bile ducts larger than the diameter of the accompanying portal vein at the level of the area or higher.
9) A severe arterial-portal or arterial-venous shunt is present.
10) Severe mental impairment.
11) Severe allergy to iodine contrast medium or other drugs.
12) Pregnant or lactating patients.
13) Other patients who are deemed unsuitable as subjects by the investigator (or subspecialist).
14) Previous radiation therapy for hepatocellular carcinoma.

Study & Design

• Study Type: Interventional
• Study Design: Not specified